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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cement, bone, vertebroplasty
Product CodeNDN
Regulation Number 888.3027
Device Class 2


Premarket Reviews
ManufacturerDecision
AAP BIOMATERIALS GMBH
  SUBSTANTIALLY EQUIVALENT 2
ALGEA THERAPIES
  SUBSTANTIALLY EQUIVALENT 1
AOI MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARTHROCARE CORP.
  SUBSTANTIALLY EQUIVALENT 2
ASCENDX SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
BENVENUE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOPSYBELL S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
BM KOREA CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
BONWRX LTD
  SUBSTANTIALLY EQUIVALENT 1
CARDINAL HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
CAREFUSION
  SUBSTANTIALLY EQUIVALENT 2
CROSSTREES MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
DEPUY SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
DFINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
DRAGON CROWN MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
G-21 S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
G21 S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
GS MEDICAL CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
GS MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HANCHANG CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HYPREVENTION
  SUBSTANTIALLY EQUIVALENT 1
HYPREVENTION SAS
  SUBSTANTIALLY EQUIVALENT 1
IMEDICOM
  SUBSTANTIALLY EQUIVALENT 1
IMEDICOM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JOLINE GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC INC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC SOFAMOR DANCK USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC SOFAMOR DANEK USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEURO THERM, INC.
  SUBSTANTIALLY EQUIVALENT 1
NINGBO HICREN BIOTECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOVITA, INC.
  SUBSTANTIALLY EQUIVALENT 1
OSSEON LLC
  SUBSTANTIALLY EQUIVALENT 3
OSSEON THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PAN MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 2
PAN MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI KINETIC MEDICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SINTEA PLUSTEK, LLC
  SUBSTANTIALLY EQUIVALENT 1
SKELTEX TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SLK ORTHO LLC
  SUBSTANTIALLY EQUIVALENT 1
SOTEIRA, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
STRYKER INSTRUMENTS
  SUBSTANTIALLY EQUIVALENT 2
STRYKER INSTRUMENTS, INSTRUMENTS DIV.
  SUBSTANTIALLY EQUIVALENT 2
SYNTHES
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES (USA) LLC
  SUBSTANTIALLY EQUIVALENT 1
TECRES S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
TECRES SPA
  SUBSTANTIALLY EQUIVALENT 1
TEKNIMED SA
  SUBSTANTIALLY EQUIVALENT 2
TEKNIMED, S.A.S.
  SUBSTANTIALLY EQUIVALENT 1
TEKNIMED, SAS
  SUBSTANTIALLY EQUIVALENT 1
VEXIM SA
  SUBSTANTIALLY EQUIVALENT 1
ZAVATION LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 231 231
2015 204 204
2016 182 182
2017 191 191
2018 144 144
2019 227 227
2020 212 212
2021 344 344
2022 270 271
2023 311 315
2024 121 121

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 331 331
Leak/Splash 321 321
Appropriate Term/Code Not Available 277 277
Migration or Expulsion of Device 254 254
Improper Chemical Reaction 197 197
Chemical Problem 169 169
Fluid/Blood Leak 149 149
Break 144 144
Material Integrity Problem 96 96
Failure to Eject 95 95
Migration 87 87
Inflation Problem 66 66
Device Operates Differently Than Expected 63 63
Coagulation in Device or Device Ingredient 29 29
Packaging Problem 28 28
Fracture 25 27
Material Too Rigid or Stiff 22 22
No Apparent Adverse Event 19 19
No Flow 18 18
Compatibility Problem 17 17
Insufficient Information 16 16
Entrapment of Device 14 14
Difficult to Remove 13 13
Activation, Positioning or Separation Problem 12 12
Activation Failure 11 12
Inadequate Instructions for Healthcare Professional 11 11
Burst Container or Vessel 10 10
Crack 10 10
Difficult or Delayed Separation 10 12
Separation Failure 9 9
Material Rupture 9 9
Use of Device Problem 9 9
Decrease in Pressure 8 8
Detachment Of Device Component 8 8
Mechanical Problem 8 8
Filling Problem 8 8
Clumping in Device or Device Ingredient 6 6
Device Difficult to Setup or Prepare 6 6
Mechanical Jam 6 6
Detachment of Device or Device Component 5 5
Device Dislodged or Dislocated 5 5
Device-Device Incompatibility 5 5
Device Handling Problem 5 5
Sticking 5 5
Device Inoperable 5 5
Failure to Advance 5 5
Material Fragmentation 5 5
Loose or Intermittent Connection 4 4
Deflation Problem 4 4
Tear, Rip or Hole in Device Packaging 4 4
Improper or Incorrect Procedure or Method 4 4
Patient Device Interaction Problem 4 4
Difficult to Open or Close 4 4
Device Difficult to Maintain 4 4
Pressure Problem 4 4
Delivery System Failure 3 3
Device Disinfection Or Sterilization Issue 3 3
Patient-Device Incompatibility 3 3
Product Quality Problem 3 3
Device Damaged Prior to Use 3 3
Component Missing 3 3
Expiration Date Error 3 3
Positioning Failure 3 3
Contamination 3 3
Nonstandard Device 3 3
Excess Flow or Over-Infusion 3 3
Difficult to Insert 2 2
Device Expiration Issue 2 2
Disassembly 2 2
Failure To Adhere Or Bond 2 2
Component Falling 2 2
Chemical Spillage 2 2
Fitting Problem 2 2
Material Puncture/Hole 2 2
Material Separation 2 2
Shelf Life Exceeded 2 2
Unintended Movement 2 2
Mechanics Altered 2 2
Noise, Audible 2 2
Inaccurate Information 2 2
Physical Resistance/Sticking 1 1
Material Protrusion/Extrusion 1 1
Positioning Problem 1 1
Osseointegration Problem 1 1
Output Problem 1 1
Misassembly by Users 1 1
Temperature Problem 1 1
Ambient Temperature Problem 1 1
Biocompatibility 1 1
Device Packaging Compromised 1 1
Device Ingredient or Reagent Problem 1 1
Difficult to Advance 1 1
Extrusion 1 1
Short Fill 1 1
Problem with Sterilization 1 1
Insufficient Flow or Under Infusion 1 1
Unstable 1 1
Therapy Delivered to Incorrect Body Area 1 1
Off-Label Use 1 1
Misassembled 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 727 732
No Known Impact Or Consequence To Patient 629 629
No Consequences Or Impact To Patient 222 222
Extravasation 135 135
No Code Available 127 127
Pain 118 118
Insufficient Information 83 84
Bone Fracture(s) 82 82
Foreign Body In Patient 42 42
Nerve Damage 41 41
Pulmonary Embolism 40 40
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 37 37
Unspecified Infection 28 28
Unspecified Tissue Injury 27 27
Device Embedded In Tissue or Plaque 26 26
No Patient Involvement 24 24
No Information 23 23
Injury 23 23
Non-union Bone Fracture 23 23
Osteolysis 23 23
Hematoma 23 23
Failure of Implant 22 22
Post Operative Wound Infection 22 22
Death 18 18
Joint Laxity 17 17
Embolism/Embolus 14 14
Paralysis 13 13
Dyspnea 12 12
Embolism 11 11
Cardiac Arrest 10 10
Decreased Sensitivity 10 10
Vertebral Fracture 9 9
Spinal Cord Injury 9 9
Perforation of Vessels 9 9
Weakness 9 9
Necrosis 8 8
Cerebrospinal Fluid Leakage 8 8
Inadequate Pain Relief 8 8
Stenosis 7 7
Paraplegia 7 7
Chest Pain 7 7
Arrhythmia 7 7
Hypersensitivity/Allergic reaction 7 7
Laceration(s) 7 7
Neurological Deficit/Dysfunction 6 6
Impaired Healing 6 6
Sudden Cardiac Death 6 6
Ambulation Difficulties 6 6
Reaction 6 6
Sedation 6 6
Not Applicable 6 6
Physical Asymmetry 5 5
Numbness 5 5
Neck Pain 5 5
Neuropathy 5 5
Muscle Weakness 5 5
Therapeutic Effects, Unexpected 5 5
Pneumonia 4 4
Loss of Range of Motion 4 4
Low Blood Pressure/ Hypotension 4 4
Anaphylactic Shock 4 4
Dysphagia/ Odynophagia 4 4
Discomfort 4 4
Swelling/ Edema 4 4
Thrombosis/Thrombus 3 3
Cancer 3 3
Pleural Effusion 3 3
Blood Loss 3 3
Stroke/CVA 3 3
Inflammation 3 3
Unspecified Nervous System Problem 3 3
Hypoxia 2 2
Muscular Rigidity 2 2
Myocardial Infarction 2 2
Fever 2 2
Rash 2 2
Pulmonary Infarction 2 2
Paresis 2 2
Spinal Column Injury 2 2
Tingling 2 2
Bacterial Infection 2 2
Wound Dehiscence 2 2
Adult Respiratory Distress Syndrome 2 2
Hemorrhage/Bleeding 2 2
Embolus 2 2
Edema 2 2
Fall 2 2
Cardiac Perforation 2 2
Tissue Damage 2 2
Collapse 2 2
Thromboembolism 2 2
Respiratory Failure 2 2
Foreign Body Embolism 2 2
Speech Disorder 2 2
Ischemia Stroke 2 2
Implant Pain 2 2
Unspecified Musculoskeletal problem 1 1
Paresthesia 1 1
Tricuspid Valve Insufficiency/ Regurgitation 1 1
Intervertebral Disc Compression or Protrusion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 DePuy Spine, Inc. II Apr-03-2018
2 DePuy Spine, Inc. II Sep-03-2013
3 DePuy Spine, Inc. II Mar-18-2013
4 Howmedica Osteonics Corp. II May-05-2020
5 Medtronic Spine LLC, formerly Kyphon Inc II Mar-11-2011
6 Stryker Instruments Div. of Stryker Corporation II Mar-28-2018
7 Stryker Instruments Div. of Stryker Corporation II Aug-15-2016
8 Stryker Spine II Jul-20-2021
9 TEKNIMED SAS II Feb-06-2023
10 Zavation II Jun-01-2021
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